NCT04598126

Brief Summary

This RCT was conducted to see effects of patient education manual on pain, ROM and functional performance in patient of knee osteoarthritis. In this study the investigators were provide an educational manual as a home plan in which the investigators educate and guide patients about proper posture, life style modification, precautions and safety measures and home exercise in patient with knee osteoarthritis

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 30, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 22, 2020

Completed
Last Updated

October 28, 2020

Status Verified

October 1, 2020

Enrollment Period

8 months

First QC Date

October 19, 2020

Last Update Submit

October 26, 2020

Conditions

Keywords

Patient education manualKnee O.APainROM

Outcome Measures

Primary Outcomes (1)

  • Visual analogue scale(VAS)

    The VAS is a unidimensional measure of pain intensity.it is a continuous scale comprised of a horizontal (HVAS) or vertical (VAS) line, usually 10 centimeters (100 mm) in length. the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 )\[100-mm scale\]).

    4th day

Secondary Outcomes (1)

  • WOMAC osteoarthritis index

    4th day

Other Outcomes (4)

  • ROM Knee flexion ( Flexion Rt)

    4th day

  • ROM Knee flexion ( Flexion Lt)

    4th day

  • ROM knee Extension ( extension Rt)

    4th day

  • +1 more other outcomes

Study Arms (2)

Traditional physical therapy

ACTIVE COMPARATOR

Traditional physical therapy

Other: Traditional physical therapy

patient education manual +traditional physical therapy

EXPERIMENTAL

Patient education manual +traditional physical therapy

Other: patient education manual +traditional physical therapy

Interventions

Traditional physical therapy Ultrasound posteriorly 6 mints 4 days/week hydrocollateral pack anteriorly 10 mints 4 days/week Quadriceps isometrics 10 repetitions×1 set, 4 days/week and Hamstring muscle strechings 10 repetitions×1 set, 4 days/

Traditional physical therapy

Patient educational Manual \+ Traditional physical therapy Ultrasound posteriorly 6 mints 4 days/week hydrocollateral pack anteriorly 10 mints 4 days/week Quadriceps isometrics 10 repetitions×1 set, 4 days/week and Hamstring muscle strechings 10 repetitions×1 set, 4 days/

patient education manual +traditional physical therapy

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Idiopathic knee OA-I, II, \&III

You may not qualify if:

  • Post Traumatic OA Knees
  • Ligament instability
  • Condromalacia patellae
  • Knee replacements
  • Cognitive impairment
  • Rheumatoid arthritis
  • Meniscus injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehabilitation department CMH(Combined military hospital)

Sialkot, Punjab Province, Pakistan

Location

Related Publications (17)

  • Iqbal MN, Haidri FR, Motiani B, Mannan A. Frequency of factors associated with knee osteoarthritis. J Pak Med Assoc. 2011 Aug;61(8):786-9.

    PMID: 22356003BACKGROUND
  • Lespasio MJ, Piuzzi NS, Husni ME, Muschler GF, Guarino A, Mont MA. Knee Osteoarthritis: A Primer. Perm J. 2017;21:16-183. doi: 10.7812/TPP/16-183.

    PMID: 29035179BACKGROUND
  • Zhang Y, Jordan JM. Epidemiology of osteoarthritis. Clin Geriatr Med. 2010 Aug;26(3):355-69. doi: 10.1016/j.cger.2010.03.001.

    PMID: 20699159BACKGROUND
  • Loeser RF. Aging and osteoarthritis: the role of chondrocyte senescence and aging changes in the cartilage matrix. Osteoarthritis Cartilage. 2009 Aug;17(8):971-9. doi: 10.1016/j.joca.2009.03.002. Epub 2009 Mar 12.

    PMID: 19303469BACKGROUND
  • Liaqat M, Liaqar B, Rauf R, Bashir F. Prevalence of knee osteoarthritis and quality of life in middle aged adults. International Journal of Rehabilitation Sciences (IJRS). 2018;7(02):26-8.

    BACKGROUND
  • Wallace IJ, Worthington S, Felson DT, Jurmain RD, Wren KT, Maijanen H, Woods RJ, Lieberman DE. Knee osteoarthritis has doubled in prevalence since the mid-20th century. Proc Natl Acad Sci U S A. 2017 Aug 29;114(35):9332-9336. doi: 10.1073/pnas.1703856114. Epub 2017 Aug 14.

    PMID: 28808025BACKGROUND
  • Plotnikoff R, Karunamuni N, Lytvyak E, Penfold C, Schopflocher D, Imayama I, Johnson ST, Raine K. Osteoarthritis prevalence and modifiable factors: a population study. BMC Public Health. 2015 Nov 30;15:1195. doi: 10.1186/s12889-015-2529-0.

    PMID: 26619838BACKGROUND
  • Pal CP, Singh P, Chaturvedi S, Pruthi KK, Vij A. Epidemiology of knee osteoarthritis in India and related factors. Indian J Orthop. 2016 Sep;50(5):518-522. doi: 10.4103/0019-5413.189608.

    PMID: 27746495BACKGROUND
  • Sowers M, Karvonen-Gutierrez CA, Jacobson JA, Jiang Y, Yosef M. Associations of anatomical measures from MRI with radiographically defined knee osteoarthritis score, pain, and physical functioning. J Bone Joint Surg Am. 2011 Feb 2;93(3):241-51. doi: 10.2106/JBJS.I.00667.

    PMID: 21266638BACKGROUND
  • Jarvholm B, Lewold S, Malchau H, Vingard E. Age, bodyweight, smoking habits and the risk of severe osteoarthritis in the hip and knee in men. Eur J Epidemiol. 2005;20(6):537-42. doi: 10.1007/s10654-005-4263-x.

    PMID: 16121763BACKGROUND
  • Stubbs B, Aluko Y, Myint PK, Smith TO. Prevalence of depressive symptoms and anxiety in osteoarthritis: a systematic review and meta-analysis. Age Ageing. 2016 Mar;45(2):228-35. doi: 10.1093/ageing/afw001. Epub 2016 Jan 20.

    PMID: 26795974BACKGROUND
  • Rashan L, Hamidpour R. OsteoLuban a Novel Natural Remedy for Osteoarthritis. 2019.

    BACKGROUND
  • Creamer P, Lethbridge-Cejku M, Hochberg MC. Where does it hurt? Pain localization in osteoarthritis of the knee. Osteoarthritis Cartilage. 1998 Sep;6(5):318-23. doi: 10.1053/joca.1998.0130.

    PMID: 10197166BACKGROUND
  • Farrokhi S, Chen YF, Piva SR, Fitzgerald GK, Jeong JH, Kwoh CK. The Influence of Knee Pain Location on Symptoms, Functional Status, and Knee-related Quality of Life in Older Adults With Chronic Knee Pain: Data From the Osteoarthritis Initiative. Clin J Pain. 2016 Jun;32(6):463-70. doi: 10.1097/AJP.0000000000000291.

    PMID: 26308705BACKGROUND
  • Sharma L. Local factors in osteoarthritis. Curr Opin Rheumatol. 2001 Sep;13(5):441-6. doi: 10.1097/00002281-200109000-00017.

    PMID: 11604602BACKGROUND
  • van Tunen JAC, Peat G, Bricca A, Larsen LB, Sondergaard J, Thilsing T, Roos EM, Thorlund JB. Association of osteoarthritis risk factors with knee and hip pain in a population-based sample of 29-59 year olds in Denmark: a cross-sectional analysis. BMC Musculoskelet Disord. 2018 Aug 21;19(1):300. doi: 10.1186/s12891-018-2183-7.

    PMID: 30126395BACKGROUND
  • Mora JC, Przkora R, Cruz-Almeida Y. Knee osteoarthritis: pathophysiology and current treatment modalities. J Pain Res. 2018 Oct 5;11:2189-2196. doi: 10.2147/JPR.S154002. eCollection 2018.

    PMID: 30323653BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, KneePain

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Syed Shakil Ur-Rehman

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2020

First Posted

October 22, 2020

Study Start

December 30, 2019

Primary Completion

August 30, 2020

Study Completion

September 30, 2020

Last Updated

October 28, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations